What you need to know about the new EU regulation on products without an intended medical purpose
By: Anne Sophie Dil – Co-Founder at NAALA
Published on 22 June, 2023
Anne Sophie Dil
Co-Founder at NAALA
Published on 22 June, 2023
Non-medical purpose products, such as colored contact lenses, lip fillers, and hair or tattoo removal lasers, have gained popularity in recent years. While these products do not have a medical purpose, they can still impact the health and safety of users if not manufactured or used correctly. To address this concern, the European Union (EU) has decided to apply regulations similar to those for medical devices to these non-medical purpose products. In this blog post, we will explore the new EU regulation, effective as of June 22, 2023, and provide insights for manufacturers on compliance and safety.
These products are not medical devices because they do not have a medical purpose. However, they can still affect your health and safety if they are not made or used properly. That’s why the EU has decided to apply some of the same rules that apply to medical devices to these products as well.
The EU has a set of rules, known as the Medical Devices Regulation (MDR), that govern the safety and effectiveness of medical devices sold in the EU. However, non-medical purpose products resembling medical devices are not covered by the MDR. Therefore, to ensure consumer safety, the EU has introduced a separate regulation for these products, commonly referred to as “annex XVI products.”
- Contact lenses or other items that go into or onto your eye;
- Products that go into your body through surgery to change your anatomy or fix your body parts (except for tattoos and piercings);
- Substances or items that go under your skin or mucous membranes to fill your face or other parts of your body (except for tattoos);
- Equipment that uses suction, heat or cold to reduce, remove or destroy fat tissue, such as liposuction, lipolysis or lipoplasty;
- Equipment that uses high intensity light or electromagnetic radiation (such as infrared, visible light and ultraviolet) on your body, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatments;
- Equipment that uses electric currents or magnetic or electromagnetic fields that go through your skull to change your brain activity.
Common Specifications
Under the MDR, the EU Commission is responsible for establishing specific rules, called common specifications (CS), for annex XVI products. These CS guide manufacturers in managing product risks and ensuring safety standards. Recently, the EU Commission adopted CS for annex XVI products through Regulation (EU) 2023/11941.
Extension of Compliance Deadlines
To ease the transition for manufacturers, the new regulation extends compliance deadlines for certain annex XVI products. The extension is granted for 18 months if clinical trials are required and 30 months if a notified body’s conformity assessment is necessary. Consequently, these products can still be sold or used until December 22, 2024, and June 22, 2025, respectively, as long as they adhere to the rules outlined in the previous directive (93/42/EEC) and do not pose risks to health and safety.
Continued Benefit for Expired Certificates
Even if the certificate issued by a notified body under the previous directive has expired before the extended deadline, the regulation ensures that these products can still benefit from the extended time.
Objectives of the Regulation
The new regulation aims to alleviate the burden on notified bodies and manufacturers while preventing market shortages of annex XVI products. It also ensures consistency between the rules governing annex XVI products and those governing medical devices covered by certificates issued under the previous directive.
Implementation and Additional Resources
As of June 22, 2023, the regulation is in effect, along with the MDR’s application to annex XVI products. For a more comprehensive understanding of the new regulation and its impact on your products, we recommend reading the official text published by the EU Commission.
To delve deeper into the concept of common specifications and their importance for annex XVI products, we encourage you to refer to our previous blog post.
Questions? We are happy to discuss your specific case.
Related
In this blog post, we explain the new EU rules for products that may look like medical devices but are not, such as cosmetic lenses, lip fillers or lasers. We also discuss the common specifications that manufacturers have to follow and the transitional provisions that give them more time to comply.
In this blog post, we explain how IPL and laser equipment are regulated by the Medical Devices Regulation (MDR) and what manufacturers need to do to comply with the new rules.
In this blog post, we explain why facial fillers are considered medical devices under the Medical Devices Regulation (MDR) and what requirements apply to them. We also discuss the challenges and opportunities for manufacturers of facial fillers in the EU market.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis.